NCT00429247

Brief Summary

Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood \[disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively\] of otherwise metastases-free patients with early breast cancer. Several studies have shown that the presence of these cells is an independent factor associated with an increased incidence of early disease relapse and disease-related death. In almost 50% of the patients, adjuvant chemotherapy cannot eliminate these occult tumor cells and this is also associated with a higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Feb 2003

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 21, 2011

Status Verified

January 1, 2008

Enrollment Period

4.8 years

First QC Date

January 30, 2007

Last Update Submit

July 20, 2011

Conditions

Breast Cancer

Keywords

Occult tumor cellsMicrometastatic cellsCytokeratin-19TrastuzumabCompletion of Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

  • Compare the disease-free interval of patients with early-stage breast cancer

    3 years

Secondary Outcomes (1)

  • Elimination of CK-19 mRNA-positive CTCs.

    Assessment of CK-19 mRNA CTCs every 3 months

Study Arms (2)

1

EXPERIMENTAL

Her

Drug: Trastuzumab

2

NO INTERVENTION

Follow up

Interventions

TrastuzumabDRUG

Trastuzumab,first administration at the dose of 8mg/Kg IV, subsequent administrations at the dose of 6mg/Kg IV,every 3 weeks for 6 cycles

Also known as: Herceptin
1

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years.
  • Performance status (World Health Organization \[WHO\]) \< 3
  • Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
  • Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function ( creatinine \< 2 mg/dl)
  • Adequate cardiac function (left ventricular ejection fraction \[LVEF\] \> 50%).
  • Informed consent
  • Histologically or cytologically confirmed breast adenocarcinoma
  • Prior surgical excision of the primary breast tumor
  • Prior completion of standard adjuvant chemotherapy and/or radiotherapy
  • Locally advanced disease after the completion of neo-adjuvant chemotherapy, surgical excision and radiotherapy provided that there was no evidence of local or metastatic disease
  • Absence of any clinical or laboratory evidence of metastatic disease
  • Detection of CTCs and/or DTCs (when it could be feasible) before the initiation and/or after the completion of adjuvant chemotherapy and/or radiotherapy
  • Expression of HER2/c-neu on the primary tumor is not mandatory

You may not qualify if:

  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Other concurrent uncontrolled illness
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or nursing
  • Positive pregnancy test
  • History of allergic reaction attributed to trastuzumab (HERCEPTIN)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Vassilis Georgoulias, MD

    University Hospital of Crete, Dep of Medical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2007

First Posted

January 31, 2007

Study Start

February 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 21, 2011

Record last verified: 2008-01

Locations

GR(1)